Systems, devices, and/or methods for managing transdermal patches

ABSTRACT

Certain exemplary embodiments can provide a system, machine, device, manufacture, circuit, composition of matter, and/or user interface adapted for and/or resulting from, and/or a method and/or machine-readable medium comprising machine-implementable instructions for, activities that can comprise and/or relate to, controlling delivery of a transdermally-delivered medication, certain embodiments including a flux controller.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims priority to, and incorporates by referenceherein in its entirety, U.S. Provisional Patent Application 62/802,288,filed 7 Feb. 2019.

BRIEF DESCRIPTION OF THE DRAWINGS

A wide variety of potential, feasible, and/or useful embodiments will bemore readily understood through the herein-provided, non-limiting,non-exhaustive description of certain exemplary embodiments, withreference to the accompanying exemplary drawings in which:

FIG. 1 is an edge view of an exemplary embodiment of a system;

FIG. 2 is a side view of an exemplary embodiment of a system;

FIG. 3 is a side view of an exemplary embodiment of a system;

FIG. 4 is a side view of an exemplary embodiment of a system;

FIG. 5 is a side view of an exemplary embodiment of a system;

FIG. 6 is a side view of an exemplary embodiment of a system;

FIG. 7 is a side view of an exemplary embodiment of a system;

FIG. 8 is a side view of an exemplary embodiment of a system;

FIG. 9 is a side view of an exemplary embodiment of a system;

FIG. 10 is a side view of an exemplary embodiment of a system;

FIG. 11 is a section view of an exemplary embodiment of a system; and

FIG. 12 is a side view of an exemplary embodiment of a system.

DESCRIPTION

Certain exemplary embodiments can provide a system, machine, device,manufacture, circuit, composition of matter, and/or user interfaceadapted for and/or resulting from, and/or a method and/ormachine-readable medium comprising machine-implementable instructionsfor, activities that can comprise and/or relate to, controlling deliveryof a transdermally-delivered medication, certain embodiments including aflux controller.

Referring to FIGS. 1-12, certain exemplary embodiments from a widevariety of possible embodiments of system 1000 can comprise a fluxcontroller (also referred to herein as a “barrier”) 1200 that ispositioned and/or configured to be positioned between a delivery face1170 of a transdermal patch 1100 and the outer layer of skin (i.e.,epidermis and/or stratum corneum) 1300 of a subject to be treated with amedication that is transdermally-delivered from delivery face 1170 ofpatch 1100 to the subject. Barrier 1200 can be configured to manage,control, direct, channel, block, impede, reduce, and/or slow a flux orflow of the medication from a corresponding portion of delivery face1170 to skin 1300, thereby providing, over a given interval of time, alower dose of the medication than would occur without barrier 1200 inplace.

FIG. 1 is an edge view of an exemplary embodiment of system 1000,showing an impermeable backing 1140 that can be adhered to a back face1160 of patch 1100. Barrier 1200 can be positioned between delivery face1170 of patch 1100 and skin 1300. Patch 1100 can be adhered to skin 1300by adhesive 1120.

FIG. 2 is a side view of an exemplary embodiment of system 1000, showingpatch 1100, adhesive 1120, and barrier 1200 (covering most of patch1100).

FIG. 3 is a side view of an exemplary embodiment of system 1000, showingimpermeable backing 1140 adhered to and completely covering patch 1100,which is applied to skin 1300.

FIG. 4 is a side view of an exemplary embodiment of system 1000, showinga barrier sheet 1230 that is formed from barrier material. Also shownare substantially rectangular pre-cut and/or perforated shaped barriers1220, 1210, and 1205, each of which can be separated from barrier sheet1230 and/or each other to define all or a portion of a barrier 1200.Shaped barrier 1220 can be sized and/or configured to control, block,impede, reduce, and/or slow a flow or flux of the medication from acorresponding portion of delivery face 1170 of patch 1100 to skin 1300.For example, by covering 20 percent of delivery face 1170, shapedbarrier 1220 can be configured to control, block, impede, reduce, and/orslow 20 percent of the labeled and/or designed flow from patch 1100 toskin 1300. A table (paper and/or software app) can be provided forlooking-up a given manufacturer, medication, and dosage to determinewhat size and/or shape of shaped barrier to select to achieve a desiredreduction in the labeled and/or designed flow from patch 1100 to skin1300.

FIG. 5 is a side view of an exemplary embodiment of system 1000, showingshaped barriers 1220, 1210, and 1205, as removed from the reminder of abarrier sheet 1230 (see FIG. 4), and as positioned on delivery face 1170to control, block, impede, reduce, and/or slow a medication flow frompatch 1100 to skin 1300. For example, shaped barriers 1220, 1210, and1205 can be configured to collectively cover a portion (e.g., 35percent) of delivery face 1170, while a portion (e.g., 65 percent) ofdelivery face 1170 remains uncovered by barrier material. Likewise,shaped barriers 1220, 1210, and 1205 can be configured to collectivelycontrol, block, impede, reduce, and/or slow a portion (e.g., 35 percent)of the labeled and/or designed medication flow while a portion (e.g., 65percent) of the medication flow is unimpeded by barrier material, andthus the patient receives only 65 percent of the labeled and/or designedmedication flowrate.

FIG. 6 is a side view of an exemplary embodiment of system 1000, showingshaped barriers 1220 and 1205 positioned on delivery face 1170 tocontrol, block, impede, reduce, and/or slow the medication flow frompatch 1100 to skin 1300. In this example, because fewer shaped barriersare present, a smaller portion of medication (e.g., 25 percent) can becontrolled, blocked, impeded, reduced, and/or slowed from flowing frompatch 1100 to skin 1300, while a larger portion (e.g., 75 percent) ofdelivery face 1170 is uncovered by barrier material and thus a largerportion (e.g., 75 percent) of medication can flow as designed from patch1100 to skin 1300.

FIG. 7 is a side view of an exemplary embodiment of system 1000, showingbarrier sheet 1230. Also shown are multiple instances of substantiallycircular pre-cut and/or perforated shaped barriers, e.g., 1220, 1210,and 1205, each of which can define a corresponding portion of barriersheet 1230, and/or each of which can define all or a portion of abarrier 1200.

As an example, shaped barrier 1220 can be sized and/or configured tocontrol, block, impede, reduce, and/or slow a flow or flux of themedication from a corresponding portion of patch 1100 to skin 1300. Forexample, by covering 20 percent of delivery face 1170, shaped barrier1220 can be configured to block 20 percent of the labeled and/ordesigned flow from patch 1100 to skin 1300.

FIG. 8 is a side view of an exemplary embodiment of system 1000, showingshaped barriers 1220, 1210, and 1205 positioned on and/or adjacentdelivery face 1170 to block and/or control a medication flow from patch1100. For example, shaped barriers 1220, 1210, and 1205 can beconfigured to collectively cover a portion (e.g., 35 percent) ofdelivery face 1170 while a portion (e.g., 65 percent) of delivery face1170 is uncovered by barrier material. Likewise, shaped barriers 1220,1210, and 1205 can be configured to collectively control, block, impede,and/or slow a portion (e.g., 35 percent) of the labeled and/or designedmedication flux and/or flow while a portion (e.g., 65 percent) of themedication flux and/or flow is uncontrolled and/or unimpeded by barriermaterial, and thus the patient receives only 65 percent of themedication.

FIG. 9 is a side view of an exemplary embodiment of system 1000, showingbarrier 1200. In this embodiment, barrier 1200 defines a plurality ofapertures 1250 therethrough, the apertures 1250 configured to allow aportion of the medication to pass therethrough to the skin. For example,barrier 1200 can be configured as a semi-permeable or permeable barriermaterial, such as a layer, film, foil, and/or tape that can bepositioned to cover all or a portion of unshown delivery face 1170.Apertures 1250 can be uniformly and/or non-uniformly distributed acrossbarrier material in a random, predetermined, and/or arrayed pattern.Apertures 1250 can be uniformly and/or non-uniformly sized and/ordimensioned (e.g., diameter and/or average width).

FIG. 10 is a side view of an exemplary embodiment of system 1000,showing a barrier sheet 1230 that is formed from barrier material. Alsoshown are substantially rectangular pre-cut and/or perforated shapedbarriers 1220, 1210, and 1205, each of which can be separated frombarrier sheet 1230 and/or each other to define all or a portion of abarrier 1200. Shaped barriers 1220, 1210, and/or 1205 can be labeled toindicate their flow control capability. As shown in this example, shapedbarrier 1220 has a tab 1280 that is labeled, while shaped barrier 1210and 1205 are directly labeled.

FIG. 11 is a cross-sectional view, taken at section A-A of FIG. 10, ofan exemplary embodiment of system 1000, showing a barrier 1200 having afirst barrier backing 1260 and a second barrier backing 1270. Either ofbarrier backings 1260 and 1270 can be removed from barrier 1200 asneeded to apply barrier 1200 to unshown patch 1100 or skin 1300. Barrier1200 can be supplied with a first adhesive layer 1265 that attaches itto first barrier backing 1260 and/or allows barrier 1200 to be attachedto unshown patch 1100 or skin 1300. Likewise, barrier 1200 can besupplied with a second adhesive layer 1275 that attaches it to secondbarrier backing 1270 and/or allows it to be attached to unshown patch1100 or skin 1300. Alternatively, barrier 1200 can be unattached to orattached by other mechanisms, such as interconnections between shapedbarriers and/or static charge, to first barrier backing 1260 and/orsecond barrier backing 1270.

The barrier material can have a predetermined (e.g., 50, 70, 75.2, 80,84.93, 90, or 95, etc. percent (including all real number values andsubranges therebetween)) medication impermeability, and thus the barriermaterial would control, block, impede, reduce, and/or slow a portion(e.g., 50, 70, 75.2, 80, 84.93, 90, or 95, etc. percent (including allreal number values and subranges therebetween)) of the labeled and/ordesigned flow of medication from patch 1100 to skin 1300. The barriermaterial can be configured function as a barrier for at least the lifeof the patch and/or can have properties sufficient to control, block,impede, reduce, and/or slow a portion (e.g., 50, 70, 75.2, 80, 84.93,90, or 95, etc. percent (including all real number values and subrangestherebetween)) of the labeled and/or designed flow of medication frompatch 1100 to skin 1300, such as being non-dissolving, tear-resistant,child-resistant, puncture-resistant, fold-resistant, chemicallyresistant, UV-resistant, opaque, translucent, transparent, chemicallyinert, medication-compatible, biocompatible, non-toxic, and/or noteliciting any undesirable local or systemic effects in the patient, etc.The barrier material can be metallic, polymeric, co-extruded, laminated,labeled, printed, printable, non-printable, writeable, non-writable,blank, textured, smooth, and/or colored.

Suitable barrier materials can include any one of or effectivecombination of: metal foils, metalized polyfoils, composite foils,and/or films containing polyester such as polyester terephthalate,polyester or aluminized polyester, polytetrafluoroethylene, polyetherblock amide copolymers, polyethylene methyl methacrylate blockcopolymers, polyurethanes, polyvinylidene chloride, nylon, siliconeelastomers, rubber-based polyisobutylene, styrene, styrene-butadiene andstyrene-isoprene copolymers, polyethylene, OPP (oriented polypropylene),PPP (polypropylene), BOPP (biaxially-oriented polypropylene), CPP (castpolypropylene), VMCPP (metallized cast polypropylene), LDPE (low densitypolyethylene), LLDPE (linear low density polyethylene), EVA(ethylene-vinyl acetate), PET (polyethylene terephthalate), paper,aluminum, nylon, polyester, mylar, Barex®, rubber-modified,acrylonitrile/methylacrylate copolymer, and/or polyacrylontrilecopolymer resin, such as those materials available from Polynova ofRichmond, British Columbia, Canada, BP Chemicals, Inc., Cleveland, Ohio,and/or Apple Converting of Oneonta, N.Y.

Any utilized barrier material, such as barrier 1200 and/or barrierportion 1205, 1210, and/or 1220 can be provided and/or packagedpre-attached to patch 1100, unattached but with patch 1100, and/orseparately from (and thus unattached to) patch 1100. When providedunattached, the barrier material can be attached to patch 1100 by thepatient and/or caregiver prior to application to skin 1300, or can besimply inserted and/or positioned between patch 1100 and skin 1300(e.g., without first attaching barrier 1200 to patch 1100). The barriermaterial can be provided as a solid sheet that can be manually cut to adesired size.

A sheet of barrier material, which potentially is mated and/ornondestructively releasably attached to a barrier backing, can beprinted, labeled, marked, pre-cut, and/or perforated to define barrierportions 1205, 1210, 1220 having predetermined shapes, such as ovals,circles, rectangles, squares, hexagons, and/or any shape configured tominimize the potential for unintentionally tearing that barrier portion.

Any of barrier portions 1205, 1210, 1220, can be provided with one ormore non-destructively removable barrier backings and/or gripsconfigured to allow that portion to be easily manually grasped andseparated from delivery face 1170, skin 1300, and/or the remainder ofbarrier 1200.

Any barrier 1200 and/or barrier portion 1205, 1210, and/or 1220 caninclude a string, flag, tab 1280, and/or other indicator thatpotentially extends beyond and/or outside patch 1100 and/or is sized,shaped, printed, labeled, colored, textured, and/or patterned, etc. toindicate the type and/or size of barrier and/or percentage of medicationdelivery reduction provided.

The barrier material can have a thickness sufficient to control and/orblock delivery of the medication from the portion of the patch 1100 thatis covered by barrier 1200 and/or barrier portion 1205, even when patch1100 utilizes micro-needles to deliver the medication. For example, thebarrier material can have a thickness of about 0.0005 inch to about 0.1inch (including all real number values and subranges therebetween).

Medications can include nicotine, opioids, heroin, fentanyl, methadone,cocaine, caffeine, buprenorphine, morphine, buspirone, hormones, such asestrogen, progestin, estradiol, and/or testosterone, nitroglycerin,scopolamine, clonidine, selegiline, methylphenidate, vitamin B12,5-Hydroxytryptophan (5-HTP), rivastigmine, pramipexole, propentofylline,rotigotine, and/or chiral drugs, for example, ceftriaxone, thalidomide,propranolol, ibuprofen, ketoprofen, naproxen, peroxetine, finasteride,sertraline, paclitaxel, terfenadine, verapamil, enalapril, lisinopril,ifosamide, methyldopa, indacrinone, bupivacaine, loxiglumide,amlodipine, pyridinium, levoslmedan, ondansetron, salmeterol, ketorolac,doxazosin, cisapride, albuterol, oxybutynin, selective serotoninreuptake inhibitors such as fluoxetine, loratadine, fexofenadine,cetirizine, formoterol, triptans such as sumatriptan, doxazosin,zolpidem, sibutramine, atorvastatin, nadolol, abacavir, citalopram,nifedipine, glitazones such as troglitazone, progliotazone, androsiglitazone, clorazepate, lorazepam, oxazepam, temazepam, omeprazole,levofloxacrn, captopril, and diltiazem.

More generally, medications can include therapeutic agents in any andall of the therapeutic areas including, but not limited to: narcotics,addictive drugs, antibiotics (including antimicrobial s, antibacterials, antimycobacterials, antimalerials, antiamebics, anthelminics,antifungal s, and antiviral s), neoplastic agents, agents affecting theimmune response (including steroidal and non-steroidal anti-inflammatoryagents), blood calcium regulators, peptide and protein hormones, agentsuseful in glucose regulation, antithrombotics and hemostatics,antihyperlipidemic agents, thyromimetic and antithyroid drugs, antiulceragents, histamine receptor agonists and antagonists, inhibitors ofallergic response, local anesthetics, analgesics and analgesiccombinations, antipsychotics, anti-anxiety agents, antidepressantsagents, anorexigenics, bone-active agents, diagnostic agents, and amixture thereof. Additional examples include: antidiarrheals,antimigraine preparations, antimotion sickness agents, antinauseants,antiparkinsonism drugs, antipruritics, antipyretics, antispasmodics(including gastrointestinal, urinary, skeletal, and smooth-muscle),anticholinergics, sympathomimetics, xanthine derivatives, cardiovascularpreparations (including calcium channel blockers, beta-blockers,antiarrythmics, antihypertensives, diuretics, vasodilators includinggeneral coronary, peripheral and cerebral), central nervous systemstimulants including cough and cold preparations, decongestants,diagnostics, hormones, immunosuppressives, parasympatholytics,parasympathomimetics, sedatives, tranquilizers, and/or mixtures thereof.

Stated differently, the term “medication” as used herein is intended tohave the broadest reasonable meaning, and can be used interchangeablywith “drug”, “active agent”, “pharmaceutical”, “medicament”, and/or anyphrase indicating a composition of matter intended to provide abeneficial effect including a therapeutic, prophylactic,pharmacological, and/or physiological substance, cosmetic and/orpersonal care preparations, and/or combinations and/or mixtures thereof.More specifically, any substance that is capable of producing apharmacological response, localized and/or systemic, irrespective ofwhether therapeutic, diagnostic, cosmetic, and/or prophylactic innature. It should be noted that the active agents can be used singularlyand/or in combinations and/or mixtures. There is no limitation on thetype of active agent that can be used. The medication can be indifferent forms depending on the solubility, flux, and/or releasecharacteristics desired, such as neutral molecules, components ofmolecular complexes, and/or pharmaceutically acceptable salts, freeacids, and/or bases, and/or quaternary salts of the same. Simplederivatives of the medications such as pharmaceutically acceptableethers, esters, amides, and the like that have desirable retentionand/or release characteristics but which are easily metabolized at bodypH, and/or enzymes, pro-active forms, pro-drugs, and/or the like, alsocan be employed.

It should be appreciated that one or more of these and other medicationsdescribed herein can exist in many pharmaceutically acceptable salts.Examples of such salts include those generated by using inorganic agents(i.e., inorganic cations such as sodium, potassium, calcium, etc.,and/or inorganic anions such as chloride, bromide, etc.) and/or organicagents (i.e., organic cations such as piperazinyl, triazinyl, etc.,and/or organic anions such as citrates, tartarates, tosylates, etc). Inaddition, these medications also can be present as polymorphs and/orisomers. Examples of polymorphs include monohydrates, dihydrates,hemi-hydrates, etc., as well those high-melting and low-meltingpolymorphs. These polymorphs can be characterized using X-raycrystallographic techniques and/or other well-known techniques in theart. Examples of isomers include geometric and optical isomers. Further,the pharmaceutical art has recognized that such salts, isomers, andpolymorphs, as well as prodrugs, analogs, and metabolites for thesedrugs can be therapeutically effective as well and/or can be substitutedwith ease.

It also should be recognized that the term “medication” as used hereinrefers to practically any chemical substance that has pharmacologicalactivity and/or biological activity, as well as those substances thatcan be used for diagnostic and/or cosmetic purposes. Thus, vitamins,such as vitamin A, C, E, K, and/or various B complexes, veterinarydrugs, and/or cosmetic agents, such as wrinkle-reducing agents(including anti-oxidants, for example, ascorbic acid, ascorbylpalmitate, catechins, an polyphenol compounds), depilating agents(including calcium salt, thioglycolic acid, and/or calcium hydroxide),hair-growing agents (including relaxin, cyproterone acetate,spironolactor, flutamide, and/or minoxidil), depigmenting agents(including sulfites, bisulfites, and/or metabisulfites, and/or alkalineearth and/or alkaline earth metal compounds thereof), are also included.Further, the term “medication” includes peptides, proteins,carbohydrates, fats, etc. that are known to exert biological and/orpharmacological effects.

A sealable container (e.g., bag, envelop, or pouch, etc.) 1500 can beprovided with patch 1100 and/or barrier 1200 to allow for safe disposalof a new or used patch 1100 (with or without barrier 1200 attachedthereto) by placing the patch 1100 within the container and then sealingthe container, such as via a sliding zipper, adhesive, and/or othercontainer sealing mechanism.

FIG. 12 is a side and/or perspective view of an exemplary embodiment ofsystem 1000, showing a sealable container (e.g., bag, envelop, or pouch,etc.) 1500 that can be included with a patch and/or barrier to allow forsafe disposal of a used patch 1500 (with or without a barrier attachedthereto) by placing the used patch 1500 within container 1400 and thensealing the container 1400, such as via a sliding zipper, adhesive,and/or other container sealing mechanism. For example, a sealablecontainer can include a top 1430, a bottom 1410, and an adhesive strip1420 attached to, e.g., bottom 1410. Once a used patch 1500 is insertedinto container 1400 before it is sealed, adhesive strip 1420 can beexposed to allow top 1430 to seal to bottom 1410, thereby sealingcontainer 1400. Note that the sealable container can be provided with apatch or barrier, potentially being non-destructably removably attachedto a patch or barrier and then removed prior to their use. U.S. Pat. No.8,623,404 is incorporated herein by reference in its entirety and forits discussion of transdermal patch pouches.

Each of the following patent publications is incorporated herein byreference in its entirety and for its discussion of, as relevant,transdermal patches, barriers, backings, adhesives, containers, sealingmechanisms, medications, materials, and/or configurations: EPO 559411A1,U.S. Pat. Nos. 5,473,966, 5,733,571, 5,804,215, 8,784,880, and9,289,397, and International Patent Applications WO2001068062A2,WO2017125455A1, and WO2018231219A1.

Certain exemplary embodiments provide a system for controlling deliveryof a transdermally-delivered medication, comprising:

-   -   a flux controller that is configured to control a delivery        flowrate of the medication to skin of a patient from a delivery        face of a skin-attachable transdermal patch;    -   the patch; and/or    -   a substantially impermeable envelope configured to sealingly        contain the patch and the flux controller,    -   wherein:        -   the flux controller defines a substantially impermeable            portion having a plurality of apertures therethrough;        -   each of the plurality of apertures is sized to allow the            medication to permeate therethrough from the patch to the            skin;        -   the plurality of apertures defines a predetermined reduction            in a labeled medication flowrate for the patch;        -   the plurality of apertures are dispersed in a predetermined            pattern;        -   the plurality of apertures are dispersed in a random            pattern;        -   the plurality of apertures are dispersed in an array;        -   the flux controller is non-destructively removeably adhered            to a backing;        -   the flux controller is configured to be non-destructively            removed, from a backing to which it is adhered, prior to            being paired with the patch;        -   the patch is configured to be attached to the skin;        -   the flux controller is configured to be attached to the            skin;        -   the flux controller is configured as a semi-permeable tape            having adhesive attached thereto;        -   further the flux controller is configured as a            semi-permeable tape having a skin-adhering adhesive attached            thereto; and/or        -   the flux controller is configured as a semi-permeable tape            having a patch-adhering adhesive attached thereto.

Certain exemplary embodiments provide a system for controlling deliveryof a transdermally-delivered medication, comprising:

-   -   a flux controller that is configured to control a delivery        flowrate of the medication to skin of a patient from a delivery        face of a skin-attachable transdermal patch;    -   the patch; and/or    -   a substantially impermeable envelope configured to sealingly        contain the patch and the flux controller;    -   wherein:        -   the flux controller defines a substantially impermeable            portion having a plurality of apertures therethrough;        -   each of the plurality of apertures is sized to allow the            medication to permeate therethrough from the patch to the            skin; and        -   the plurality of apertures defines a predetermined reduction            in a labeled medication flowrate for the patch.        -   the plurality of apertures are dispersed in a predetermined            pattern;        -   the plurality of apertures are dispersed in a random            pattern;        -   the plurality of apertures are dispersed in an array;        -   the flux controller is non-destructively removeably adhered            to a backing;        -   the flux controller is configured to be non-destructively            removed, from a backing to which it is adhered, prior to            being paired with the patch;        -   the patch is configured to be attached to the skin;        -   the flux controller is configured to be attached to the            skin;        -   the flux controller is configured as a semi-permeable tape            having adhesive attached thereto;        -   the flux controller is configured as a semi-permeable tape            having a skin-adhering adhesive attached thereto; and/or        -   the flux controller is configured as a semi-permeable tape            having a patch-adhering adhesive attached thereto.

Certain exemplary embodiments provide a system for controlling deliveryof a system for controlling delivery of a transdermally-deliveredmedication, comprising:

-   -   a flux controller that is configured to control a delivery        flowrate of the medication to skin of a patient from a delivery        face of a skin-attachable transdermal patch;    -   wherein:        -   the flux controller defines an adjustably-sizable aperture            configured to be manually sized to allow the medication to            permeate therethrough from the patch to the skin at an            adjustable fraction of a labeled medication flowrate for the            patch.

Definitions

When the following phrases are used substantively herein, theaccompanying definitions apply. These phrases and definitions arepresented without prejudice, and, consistent with the application, theright to redefine these phrases via amendment during the prosecution ofthis application or any application claiming priority hereto isreserved. For the purpose of interpreting a claim of any patent thatclaims priority hereto, each definition in that patent functions as aclear and unambiguous disavowal of the subject matter outside of thatdefinition.

-   -   a—at least one.    -   about—around and/or approximately.    -   above—at a higher level.    -   across—from one side to another.    -   activity—an action, act, step, and/or process or portion thereof    -   adapt—to design, make, set up, arrange, shape, configure, and/or        make suitable and/or fit for a specific purpose, function, use,        and/or situation.    -   adapter—a device used to effect operative compatibility between        different parts of one or more pieces of an apparatus or system.    -   adhere—to make stick, bond, cling, cleave, hold, stick fast to        something, stay attached, and/or resist separation.    -   adhesive—a substance that adheres to a surface and/or causes        adherence between surfaces.    -   adjust—to move and/or change (something) so as to conform with        something else and/or to be in a suitable and/or more effective        arrangement and/or desired condition.    -   adjustable—configured to change, match, and/or fit.    -   after—following in time and/or subsequent to.    -   allow—to provide, let do, happen, and/or permit.    -   along—through, on, beside, over, in line with, and/or parallel        to the length and/or direction of; and/or from one end to the        other of.    -   and—in conjuction with.    -   and/or—either in conjunction with or in alternative to.    -   any—one, some, every, and/or all without specification.    -   aperture—an opening, hole, gap, passage, and/or slit.    -   apparatus—an appliance or device for a particular purpose.    -   approximately—about and/or nearly the same as.    -   area—the measure of the space within a closed 2-dimensional        region.    -   around—about, surrounding, and/or on substantially all sides of;        and/or approximately.    -   array—a matrix, table, and or arrangement of multiple units,        usually ordered, whereby the array can be organized in linear,        flat, or 3-dimensional positioning of the multiple units.    -   as long as—if and/or since.    -   associate—to join, connect together, and/or relate.    -   at—in, on, and/or near.    -   at least—not less than, and possibly more than.    -   attached—joined or secured together.    -   axis—a straight line about which a body and/or geometric object        rotates and/or can be conceived to rotate and/or a center line        to which parts of a structure and/or body can be referred.    -   backing—something that covers, forms, lines, protects, supports,        reinforces, and/or strengthens the back of something.    -   based on—indicating one or more factors that affect a        determination, but not necessarily foreclosing additional        factors that might affect that determination.    -   be—to exist in actuality.    -   between—in a separating interval and/or intermediate to.    -   by—via and/or with the use and/or help of    -   can—is capable of, in at least some embodiments.    -   cause—to bring about, provoke, precipitate, produce, elicit, be        the reason for, result in, and/or effect.    -   circuit—an electrically conductive pathway and/or a        communications connection established across two or more        switching devices comprised by a network and between        corresponding end systems connected to, but not comprised by the        network.    -   composition of matter—a combination, reaction product, compound,        mixture, formulation, material, and/or composite formed by a        human and/or automation from two or more substances and/or        elements.    -   comprising—including but not limited to.    -   conceive—to imagine, conceptualize, form, and/or develop in the        mind.    -   concentration—a measure of how much of a given substance is        mixed, dissolved, contained, and/or otherwise present in and/or        with another substance, and/or a measure of the amount of        dissolved substance contained per unit of volume and/or the        amount of a specified substance in a unit amount of another        substance, both measures defining a structure of a composition        that comprises both substances.    -   configure—to design, arrange, set up, shape, and/or make        suitable and/or fit for a specific purpose, function, use,        and/or situation.    -   configured to—designed, arranged, set up, shaped, and/or made        suitable and/or fit for a specific purpose, function, use,        and/or situation, and/or having a structure that, during        operation, will perform the indicated activity(ies). To the        extent relevant to the current application, the use of        “configured to” is expressly not intended to invoke 35 U.S.C. §        112(f) for that structure.    -   connect—to join or fasten together.    -   contain—to restrain, hold, and/or keep within limits.    -   containing—including but not limited to.    -   control—to exercise authoritative and/or dominating influence        over, cause to act in a predetermined manner, direct, adjust to        a requirement, and/or regulate.    -   controller—a device used to control a property, characteristic,        behavior, and/or effect of another device.    -   convert—to transform, adapt, and/or change.    -   corresponding—related, associated, accompanying, similar in        purpose and/or position, conforming in every respect, and/or        equivalent and/or agreeing in amount, quantity, magnitude,        quality, and/or degree.    -   coupleable—capable of being joined, connected, and/or linked        together.    -   coupling—linking in some fashion.    -   create—to bring into being.    -   define—to establish the meaning, relationship, outline, form,        and/or structure of; and/or to precisely and/or distinctly        describe and/or specify.    -   delivery—an act of conveying and/or transferring.    -   derive—to receive, obtain, and/or produce from a source and/or        origin.    -   determine—to find out, obtain, calculate, decide, deduce,        ascertain, and/or come to a decision, typically by        investigation, reasoning, and/or calculation.    -   device—a machine, manufacture, and/or collection thereof.    -   disperse—to scatter, strew, separate, drive off, move, and/or        distribute widely and/or in different directions.    -   each—every one of a group considered individually.    -   effective—sufficient to bring about, provoke, elicit, and/or        cause.    -   embodiment—an implementation, manifestation, and/or concrete        representation.    -   envelope—a bag, covering, enclosure, and/or wrapping.    -   estimate—(n) a calculated value approximating an actual        value; (v) to calculate and/or determine approximately and/or        tentatively.    -   exemplary—serving as an example, instance, and/or illustration.    -   first—a label for a referenced element in one or more patent        claims, but that label does not necessarily imply any type of        ordering to how that element (or any other elements of a similar        type) is implemented in embodiments of the claimed subject        matter.    -   flow—(n) a stream, current, and/or continuous transference; (v)        to move and/or run smoothly with unbroken continuity, as in the        manner characteristic of a fluid.    -   flowrate—the amount of fluid that flows in a given time and/or a        rate at which a unit of a flow passes a given point in a        predetermined period of time.    -   flux—a flowrate and/or rate of flow of a fluid.    -   for—with a purpose of    -   fraction—a part and/or portion of a whole and/or entirety.    -   from—used to indicate a source, origin, and/or location thereof.    -   further—in addition.    -   further—in addition.    -   generate—to create, produce, give rise to, and/or bring into        existence.    -   given—    -   having—possessing, characterized by, comprising, and/or        including, but not limited to.    -   impermeable—impervious, configured to prevent fluids (especially        liquids) to pass and/or diffuse through, and/or not permeable.    -   including—including but not limited to.    -   initialize—to prepare something for use and/or some future        event.    -   install—to connect or set in position and prepare for use.    -   into—to a condition, state, or form of    -   is—to exist in actuality.    -   label—(n) an item used to identify something and/or someone, as        a small piece of paper and/or cloth attached to an article to        designate its origin, owner, contents, use, and/or        destination; (v) to attach a label to and/or to designate and/or        describe by and/or on a label.    -   layer—a ply, strata, sheet, and/or single thickness of a        material configured to cover a surface.    -   longitudinal—of and/or relating to a length; placed and/or        running lengthwise.    -   longitudinal axis—a straight line defined parallel to an        object's length and passing through a centroid of the object.    -   manage—to exert control and/or influence over, direct, and/or        control the use, affairs, and/or interests of    -   manually—employing human rather than mechanical energy.    -   may—is allowed and/or permitted to, in at least some        embodiments.    -   medication—a substance adapted to relieve at least one symptom        of and/or cure a medical condition.    -   method—one or more acts that are performed upon subject matter        to be transformed to a different state or thing and/or are tied        to a particular apparatus, said one or more acts not a        fundamental principal and not pre-empting all uses of a        fundamental principal.    -   microgram—one one-millionth of a gram.    -   milligram—one one-thousandth of a gram.    -   mix—to combine and/or blend into one mass, stream, and/or        mixture.    -   molecule—the smallest particle of a substance that retains the        chemical and physical properties of the substance and is        composed of two or more atoms; and/or a group of like or        different atoms held together by chemical forces.    -   near—a distance of less than approximately [X].    -   no—an absence of and/or lacking any.    -   non-destructively—to perform substantially without damaging.    -   one—being and/or amounting to a single unit, individual, and/or        entire thing, item, and/or object.    -   operable—practicable and/or fit, ready, and/or configured to be        put into its intended use and/or service.    -   operative—when in operation for its intended use and/or service.    -   or—a conjunction used to indicate alternatives, typically        appearing only before the last item in a group of alternative        items.    -   outside—beyond a range, boundary, and/or limit; and/or not        within.    -   pair—(n) a quantity of two of something and/or two things that        are matched for use together; (v) to combine and/or join (one        person and/or thing) with another to form a pair.    -   parallel—of, relating to, and/or designating lines, curves,        planes, and/or surfaces everywhere equidistant.    -   patch—a covering configured to be applied to the skin.    -   patient—one who is scheduled to receive, has been admitted to        receive, or has received, health care, and/or a human or other        type of animal under supervision for health care purposes.    -   pattern—a characteristic form and/or arrangement.    -   per—for each and/or by means of.    -   permeate—to penetrate, flow through, be absorbed through,        pervade, and/or pass through the openings and/or interstices of.    -   perpendicular—intersecting at or forming substantially right        angles.    -   plurality—the state of being plural and/or more than one.    -   portion—a part, component, section, percentage, ratio, and/or        quantity that is less than a larger whole.    -   pre-—a prefix that precedes an activity that has occurred        beforehand and/or in advance.    -   predetermine—to determine, decide, and/or establish in advance.    -   prevent—to hinder, avert, and/or keep from occurring.    -   prior—before and/or preceding in time or order.    -   probability—a quantitative representation of a likelihood of an        occurrence.    -   product—something produced by human and/or mechanical effort.    -   project—to calculate, estimate, or predict.    -   provide—to furnish, supply, give, and/or make available.    -   random—selected in a substantially unbiased manner within a        predetermined range.    -   range—a measure of an extent of a set of values and/or an amount        and/or extent of variation.    -   ratio—a relationship between two quantities expressed as a        quotient of one divided by the other.    -   receive—to get as a signal, take, acquire, and/or obtain.    -   recommend—to suggest, praise, commend, and/or endorse.    -   reduce—to make and/or become lesser and/or smaller.    -   reduction—a diminishment in magnitude.    -   removably—configured to be removed.    -   remove—to eliminate, remove, and/or delete, and/or to move from        a place and/or position occupied.    -   repeat—to do again and/or perform again.    -   repeatedly—again and again; repetitively.    -   request—to express a desire for and/or ask for.    -   result—(n.) an outcome and/or consequence of a particular        action, operation, and/or course; (v.) to cause an outcome        and/or consequence of a particular action, operation, and/or        course.    -   said—when used in a system or device claim, an article        indicating a subsequent claim term that has been previously        introduced.    -   seal—to shut close, keep closed, make fast, keep secure, and/or        prevent leakage.    -   second—a label for an element in one or more patent claims, the        element other than a “first” referenced element of a similar        type, but the label does not necessarily imply any type of        ordering to how that “second” element or the “first” element is        implemented in embodiments of the claimed subject matter.    -   select—to make a choice or selection from alternatives.    -   semi-permeable—partially permeable and/or allowing passage of a        portion of.    -   set—a related plurality.    -   size—(v) to make, cut, and/or shape to a required size; (n) the        physical dimensions, proportions, magnitude, amount, and/or        extent of an entity.    -   skin—the membranous tissue forming the external covering of an        animal and consisting in vertebrates of the epidermis and        dermis.    -   skin-attachable—configured (such as via adhesive) to be attached        to skin.    -   species—a class of individuals and/or objects grouped by virtue        of their common attributes and assigned a common name; a        division subordinate to a genus.    -   store—to place, hold, and/or retain data, typically in a memory.    -   substantially—to a considerable, large, and/or great, but not        necessarily whole and/or entire, extent and/or degree.    -   support—to bear the weight of, especially from below.    -   system—a collection of mechanisms, devices, machines, articles        of manufacture, processes, data, and/or instructions, the        collection designed to perform one or more specific functions.    -   tape—a continuous narrow, flexible strip of cloth, metal, paper,        and/or plastic, having an adhesive surface.    -   that—used as the subject or object of a relative clause.    -   therapeutically effective—an amount of medication that is        sufficient to achieve the desired local or systemic effect or        result, such as to prevent, cure, diagnose, mitigate or treat a        disease or condition, when applied topically over the duration        of intended use.    -   therethrough—in one end and out another end of an object.    -   thereto—to that.    -   through—across, among, between, and/or in one side and out the        opposite and/or another side of    -   to—a preposition adapted for use for expressing purpose.    -   transdermal—absorbed through and/or by way of the unbroken skin,        and often referring to medications applied in time-release forms        (skin patches).    -   transform—to change in measurable: form, appearance, nature,        and/or character.    -   transmit—to send as a signal, provide, furnish, and/or supply.    -   treatment—an act, manner, or method of handling and/or dealing        with someone and/or something.    -   upon—immediately or very soon after; and/or on the occasion of.    -   use—to put into service.    -   via—by way of and/or utilizing.    -   weight—a force with which a body is attracted to Earth or        another celestial body, equal to the product of the object's        mass and the acceleration of gravity; and/or a factor and/or        value assigned to a number in a computation, such as in        determining an average, to make the number's effect on the        computation reflect its importance, significance, preference,        impact, etc.    -   when—at a time and/or during the time at which.    -   wherein—in regard to which; and; and/or in addition to.    -   which—a pronoun adapted to be used in clauses to represent a        specified antecedent; and/or what particular one or ones.    -   with—accompanied by.    -   with regard to—about, regarding, relative to, and/or in relation        to.    -   with respect to—about, regarding, relative to, and/or in        relation to.    -   within—inside the limits of.    -   zone—a region and/or volume having at least one predetermined        boundary.        Note

Various substantially and specifically practical and useful exemplaryembodiments of the claimed subject matter are described herein,textually and/or graphically, including the best mode, if any, known tothe inventor(s), for implementing the claimed subject matter by personshaving ordinary skill in the art. References herein to “in oneembodiment”, “in an embodiment”, or the like do not necessarily refer tothe same embodiment.

Any of numerous possible variations (e.g., modifications, augmentations,embellishments, refinements, and/or enhancements, etc.), details (e.g.,species, aspects, nuances, and/or elaborations, etc.), and/orequivalents (e.g., substitutions, replacements, combinations, and/oralternatives, etc.) of one or more embodiments described herein mightbecome apparent upon reading this document to a person having ordinaryskill in the art, relying upon his/her expertise and/or knowledge of theentirety of the art and without exercising undue experimentation. Theinventor(s) expects any person having ordinary skill in the art, afterobtaining authorization from the inventor(s), to implement suchvariations, details, and/or equivalents as appropriate, and theinventor(s) therefore intends for the claimed subject matter to bepracticed other than as specifically described herein. Accordingly, aspermitted by law, the claimed subject matter includes and covers allvariations, details, and equivalents of that claimed subject matter.Moreover, as permitted by law, every combination of the herein describedcharacteristics, functions, activities, substances, and/or structuralelements, and all possible variations, details, and equivalents thereof,is encompassed by the claimed subject matter unless otherwise clearlyindicated herein, clearly and specifically disclaimed, or otherwiseclearly unsuitable, inoperable, or contradicted by context.

The use of any and all examples, or exemplary language (e.g., “such as”)provided herein, is intended merely to better illuminate one or moreembodiments and does not pose a limitation on the scope of any claimedsubject matter unless otherwise stated. No language herein should beconstrued as indicating any non-claimed subject matter as essential tothe practice of the claimed subject matter.

Thus, regardless of the content of any portion (e.g., title, field,background, summary, description, abstract, drawing figure, etc.) ofthis document, unless clearly specified to the contrary, such as viaexplicit definition, assertion, or argument, or clearly contradicted bycontext, with respect to any claim, whether of this document and/or anyclaim of any document claiming priority hereto, and whether originallypresented or otherwise:

-   -   there is no requirement for the inclusion of any particular        described characteristic, function, activity, substance, or        structural element, for any particular sequence of activities,        for any particular combination of substances, or for any        particular interrelationship of elements;    -   no described characteristic, function, activity, substance, or        structural element is “essential”; and    -   within, among, and between any described embodiments:        -   any two or more described substances can be mixed, combined,            reacted, separated, and/or segregated;        -   any described characteristic, function, activity, substance,            component, and/or structural element, or any combination            thereof, can be specifically included, duplicated, excluded,            combined, reordered, reconfigured, integrated, and/or            segregated;        -   any described interrelationship, sequence, and/or dependence            between any described characteristics, functions,            activities, substances, components, and/or structural            elements can be omitted, changed, varied, and/or reordered;        -   any described activity can be performed manually,            semi-automatically, and/or automatically;        -   any described activity can be repeated, performed by            multiple entities, and/or performed in multiple            jurisdictions.

The use of the terms “a”, “an”, “said”, “the”, and/or similar referentsin the context of describing various embodiments (especially in thecontext of the following claims) are to be construed to cover both thesingular and the plural, unless otherwise indicated herein or clearlycontradicted by context.

The terms “comprising,” “having,” “including,” and “containing” are tobe construed as open-ended terms (i.e., meaning “including, but notlimited to,”) unless otherwise noted.

When any number or range is described herein, unless clearly statedotherwise, that number or range is approximate. Recitation of ranges ofvalues herein are merely intended to serve as a shorthand method ofreferring individually to each separate value falling within the range,unless otherwise indicated herein, and each separate value and eachseparate sub-range defined by such separate values is incorporated intothe specification as if it were individually recited herein. Forexample, if a range of 1 to 10 is described, that range includes allvalues therebetween, such as for example, 1.1, 2.5, 3.335, 5, 6.179,8.9999, etc., and includes all sub-ranges therebetween, such as forexample, 1 to 3.65, 2.8 to 8.14, 1.93 to 9, etc., even if those specificvalues or specific sub-ranges are not explicitly stated.

When any phrase (i.e., one or more words) appearing in a claim isfollowed by a drawing element number, that drawing element number isexemplary and non-limiting on claim scope.

No claim or claim element of this document is intended to invoke 35 USC112(f) unless the precise phrase “means for” is followed by a gerund.

Any information in any material (e.g., a United States patent, UnitedStates patent application, book, article, web page, etc.) that has beenincorporated by reference herein, is incorporated by reference herein inits entirety to its fullest enabling extent permitted by law yet only tothe extent that no conflict exists between such information and theother definitions, statements, and/or drawings set forth herein. In theevent of such conflict, including a conflict that would render invalidany claim herein or seeking priority hereto, then any such conflictinginformation in such material is specifically not incorporated byreference herein. Any specific information in any portion of anymaterial that has been incorporated by reference herein that identifies,criticizes, or compares to any prior art is not incorporated byreference herein.

Applicant intends that each claim presented herein and at any pointduring the prosecution of this application, and in any application thatclaims priority hereto, defines a distinct patentable invention and thatthe scope of that invention must change commensurately if and as thescope of that claim changes during its prosecution. Thus, within thisdocument, and during prosecution of any patent application relatedhereto, any reference to any claimed subject matter is intended toreference the precise language of the then-pending claimed subjectmatter at that particular point in time only.

Accordingly, every portion (e.g., title, field, background, summary,description, abstract, drawing figure, etc.) of this document, otherthan the claims themselves and any provided definitions of the phrasesused therein, is to be regarded as illustrative in nature, and not asrestrictive. The scope of subject matter protected by any claim of anypatent that issues based on this document is defined and limited only bythe precise language of that claim (and all legal equivalents thereof)and any provided definition of any phrase used in that claim, asinformed by the context of this document when reasonably interpreted bya person having ordinary skill in the relevant art.

What is claimed is:
 1. A system for manually controlling delivery of atransdermally-delivered medication, comprising: a transdermal patchdefining a delivery face, the transdermal patch configured to delivermedication to the skin of a patient; a flux controller that isconfigured for the patient to selectively manually control a deliveryflowrate of the medication to the skin of the patient from the deliveryface of the transdermal patch; and a impermeable envelope configured tosealingly contain the patch and the flux controller; wherein: the fluxcontroller defines a selectively patient-sizable impermeable portionhaving a plurality of apertures therethrough; each of the plurality ofapertures is sized to allow the medication to permeate therethrough fromthe patch to the skin; the plurality of apertures are configured todefine a predetermined reduction in a labeled medication flowrate forthe patch; the plurality of apertures are dispersed in a pattern; theflux controller is non-destructively removeably adhered to a backing;the flux controller is configured to be non-destructively manuallyremoved by the patient from the backing prior to being paired by thepatient with the patch; the patch is configured to be attached to theskin; the flux controller is configured to be attached to the skin; theflux controller is configured as a semi-permeable tape having adhesiveattached thereto; the semi-permeable tape has a skin-adhering adhesiveattached thereto; and the semi-permeable tape has a patch-adheringadhesive attached thereto.
 2. A system for manually controlling deliveryof a transdermally-delivered medication, comprising: a transdermal patchdefining a delivery face, the transdermal patch configured to delivermedication to the skin of a patient; a flux controller that isconfigured for the patient to selectively manually control a deliveryflowrate of the medication to the skin of the patient from the deliveryface of the transdermal patch; and wherein: the flux controller definesa selectively patient-sizable impermeable portion having a plurality ofapertures therethrough; each of the plurality of apertures is sized toallow the medication to permeate therethrough from the patch to theskin; and the plurality of apertures are configured to define apredetermined reduction in a labeled medication flowrate for the patch.3. The system of claim 2, wherein: the plurality of apertures aredispersed in a pattern.
 4. The system of claim 2, wherein: the pluralityof apertures are dispersed in a random pattern.
 5. The system of claim2, wherein: the plurality of apertures are dispersed in a predeterminedarray pattern.
 6. The system of claim 2, wherein: the flux controller isnon-destructively removeably adhered to a backing.
 7. The system ofclaim 2, wherein: the flux controller is configured to benon-destructively removed, from a backing to which it is adhered, priorto being paired with the patch.
 8. The system of claim 2, wherein: thepatch is configured to be attached to the skin.
 9. The system of claim2, wherein: the flux controller is configured to be attached to theskin.
 10. The system of claim 2, wherein: the flux controller isconfigured as a semi-permeable tape having adhesive attached thereto.11. The system of claim 2, wherein: the flux controller is configured asa semi-permeable tape having a skin-adhering adhesive attached thereto.12. The system of claim 2, wherein: the flux controller is configured asa semi-permeable tape having a patch-adhering adhesive attached thereto.13. The system of claim 2, further comprising: the patch.
 14. The systemof claim 2, further comprising: a impermeable envelope configured tosealingly contain the patch and the flux controller.
 15. A system formanually controlling delivery of a transdermally-delivered medication,comprising: a flux controller that is configured for a patient toselectively manually control a delivery flowrate of the medication toskin of the patient from a delivery face of a skin-attachabletransdermal patch; wherein: the flux controller definespatient-adjustably-sizable aperture configured to be manually sized toallow the medication to permeate therethrough from the patch to the skinat a patient-adjustable fraction of a labeled medication flowrate forthe patch.